Actively Recruiting
Decellularized Femoral Artery Allograft (Nexeon AVX) Prospective Registry
Led by LifeNet Health · Updated on 2025-04-02
100
Participants Needed
4
Research Sites
236 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Post market registry to assess the safety and efficacy of a novel decellularized human femoral artery allograft (Nexeon AVX Decellularized Femoral Artery,
CONDITIONS
Official Title
Decellularized Femoral Artery Allograft (Nexeon AVX) Prospective Registry
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be male or female, 18 years of age or older at the time of graft placement
- Have a diagnosis of end-stage renal disease (ESRD) or renal dysfunction requiring hemodialysis
- Require dialysis access to start or maintain dialysis treatment with placement of an arteriovenous (AV) access graft as a viable option
- Be able to understand the study requirements and provide written informed consent or assent
- Have provided written authorization for use and disclosure of protected health information
You will not qualify if you...
- Currently participating in another investigational drug or device study
- Known sensitivity to any processing reagents used in the product, including specific antibiotics and chemicals
- History or evidence of severe cardiac disease, recent myocardial infarction (within 6 months), ventricular arrhythmias, or unstable angina needing ongoing treatment
- History or evidence of severe peripheral vascular disease in the upper limbs
- Unable or unwilling to follow the study visit schedule
- Presence of any condition that places the participant at undue risk or may compromise data quality as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Infirmary Heath
Mobile, Alabama, United States, 36607
Actively Recruiting
2
Olive View - UCLA Medical Center
Sylmar, California, United States, 91342
Actively Recruiting
3
Harbor-UCLA Medical Center
Torrance, California, United States, 90502
Actively Recruiting
4
Sentara Norfolk General Hospital
Norfolk, Virginia, United States, 23507
Actively Recruiting
Research Team
K
Kimberly Dorsch
CONTACT
M
Monique Alston-Epps
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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